NCT01685866已完成不适用
Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- reduce the time necessary to find the venous access during inhalation anesthesia induction
研究概览
简要总结
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.
详细描述
Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged less than 7
- •DIVA score ≥ 4
- •patient needing venous peripheral access for general anesthesia
排除标准
- •no social security
- •opposition of the parent(s) to the participation of their child in the trial
研究组 & 干预措施
Vein-Viewer Vision
Other
A medical device called Vein-Viewer Vision
干预措施: Vein-Viewer Vision (Device)
no medical device
No Intervention
in the second arm, we use no medical device
结局指标
主要结局
reduce the time necessary to find the venous access during inhalation anesthesia induction
时间窗: 1 day of anesthesia
次要结局
未报告次要终点
研究者
研究点 (2)
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